Multi-country Evaluation of Early RHD in Children Across Africa for Vaccine Trial Readiness

N/ANot Yet RecruitingNCT07790302

Children's Hospital Medical Center, Cincinnati7,500 enrolled

Overview

This study will look at how many children develop rheumatic heart disease (RHD) over a 3-year period. The study will include children ages 5 to 8 who do not have RHD at the start and who live in areas where the disease is common. Each child will have a heart ultrasound (echocardiogram) once a year for 3 years to check for signs of RHD. Doctors will diagnose RHD using internationally recognized guidelines from the World Heart Federation (2023). The study will also look at how often new cases occur each year, whether rates differ by age, sex, or location, and whether any children develop acute rheumatic fever during the study.

Study Type

OBSERVATIONAL

Enrollment

7,500

Conditions

Rheumatic Heart Disease in Children

Eligibility

Sex: ALLMin age: 5 YearsMax age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 5-8 years at enrollment * Residence within participating study catchment area * Parent/guardian able to provide informed consent * Participant able to provide assent where age-appropriate (country-specific, see below) * Normal baseline echocardiogram according to study screening protocol Exclusion Criteria: * History of past ARF or RHD with or without cardiac involvement * Evidence of RHD at baseline screening * Congenital heart disease at baseline screening (excluding small PFO/ASD) * Medical conditions that would preclude safe participation or follow-up * Anticipated inability to complete study follow-up

Locations (1)

Outcomes

Primary Outcomes

Number of Participants with 3-Year Cumulative Incidence of Rheumatic Heart Disease

Proportion of participants who develop RHD during the 3-year follow-up period, defined according to the 2023 World Heart Federation (WHF) echocardiographic criteria. Participants will be considered to have reached the endpoint if RHD is identified on any follow-up echocardiogram at 12, 24, or 36 months, or if they are diagnosed with acute rheumatic fever (ARF) during follow-up.

Time frame: 3 years

Secondary Outcomes

Rate of Newly Diagnosed Rheumatic Heart Disease

Incidence of newly diagnosed RHD at each annual assessment (12, 24, and 36 months), based on the 2023 WHF echocardiographic criteria.

Time frame: 12 months, 24 months, and 36 months

Number of Participants with RHD by Age Group

Cumulative incidence of RHD stratified by age at enrollment (5-6 years versus 7-8 years).

Time frame: 3 years

Number of Participants with RHD by Sex

Cumulative incidence of RHD stratified by participant sex.

Time frame: 3 years

Number of Participants with RHD by Geographic Location

Cumulative incidence of RHD stratified by study site (Uganda, Malawi, and The Gambia)

Time frame: 3 years

Multi-country Evaluation of Early RHD in Children Across Africa for Vaccine Trial Readiness

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts